MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MAXFIRE MARXMEN STRAIGHT; FASTENER, FIXATION

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 05/20/2015

Event Type  Injury  

Event Description

It was reported patient underwent a meniscus repair procedure on (b)(6) 2015.During the procedure, three anchors pulled out.Competitor product was utilized to complete the procedure.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "care is to be taken to assure adequate fixation of the meniscal tissue at the time of surgery." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02682 / 02683).

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Examination of returned device was inconclusive.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: MAXFIRE MARXMEN STRAIGHT
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4860276
• MDR Text Key: 15590800
• Report Number: 0001825034-2015-02683
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 900320
• Device Lot Number: 111990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/29/2015; 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention